John Doucet, Ph.D., the former U.S. Food and Drug Administration (FDA) Policy Lead, Breakthrough Device Program, is the new senior director of Neurology Regulatory Affairs at MCRA, LLC (Musculoskeletal Clinical Regulatory Advisers), a medical device and biologics advisory firm and clinical research organization integrating U.S. and International Regulatory, Clinical Research, Reimbursement, Healthcare Compliance, and Quality Assurance.
In leading the Breakthrough Device Program, Doucet was involved in the granting or denial of breakthrough designation requests, and served as the Center for Devices and Radiological Health’s expert for internal and external stakeholders on the regulatory standard for obtaining the breakthrough designation for a medical device.
While at the FDA, Doucet also held the following positions: Acting Director of the Investigational Device Exemption Program, Lead Reviewer of Neurology and Physical Medicine Devices, Acting Branch Chief of Neurostimulation Devices Psychiatry Branch, and Policy Analyst of Office of Device Evaluation.
Glenn Stiegman, MCRA’s senior vice president of Clinical and Regulatory Affairs said, “MCRA is the leading advisory firm in assisting clients with U.S. regulatory initiatives. We are very pleased that John has joined our firm and will guide our clients in continuing the advancement of technology innovation. John brings tremendous value given his wealth of experience, knowledge, and leadership on the Breakthrough Device
“After 13 years as a research scientist at Johns Hopkins University,” said Dr. Doucet to OTW, “I left with critical skills such as how to identify important scientific questions, how best to answer them efficiently, and how to judge when they are answered adequately. These ‘scientific judgement’ skills provided a strong foundation for my subsequent role as a medical device regulator at the FDA, where I spent 10 years as a scientific reviewer of premarket submissions (e.g., 510(k) clearance, premarket approval (PMA)) and 2 years as the Policy Lead for the Breakthrough Device Program. Collectively, these 25+ years of scientific and regulatory experience has prepared me to serve MCRA’s clients and the public by creating efficient regulatory pathways for ‘game-changing’ medical products, and thus promote patients’ access to safe and effective products as quickly as possible.
“One of my first steps will be to promote better understanding of the promise and purpose of FDA’s Breakthrough Device Program. The Program has several regulatory and reimbursement advantages for medical device developers; however, these advantages can only be realized with early and integrated planning that addresses challenges of the entire product lifecycle (i.e., concept to commercialization). I plan to collaborate with MCRA reimbursement and clinical trial experts to ensure our clients are in the best position to take full advantage of this important Program.”
